Ability Pharmaceuticals SL, of Barcelona, Spain, gained approval from the Spanish Medicines Agency to initiate a phase I/Ib clinical trial of the anticancer drug ABTL0812 in patients with advanced cancer. This is a first-in-human study that will be conducted at Hospital Clínic Barcelona. ABTL0812 inhibits the proliferation of cancer cells through the inhibition of the mTORC1/C2 pathway with a novel mechanism of action. ABTL0812 will be administered to patient orally once daily. The drug is designed for the treatment of patients with advanced cancer such as lung or pancreatic, for whom options are limited.

Advaxis Inc., of Princeton, N.J., expanded its relationship by entering a master clinical trial agreement with GRU Cancer Center in Augusta, Ga., to conduct four phase I/II trials with Advaxis’ two lead immunotherapies: ADXS-HPV for cervical cancer and ADXS-cHER2 for breast cancer.

Fraunhofer USA Center for Molecular Biotechnology in Newark, Del., gained clearance from the FDA for an investigational new drug application involving Fraunhofer’s plant-derived malaria transmission-blocking vaccine, which targets the Pfs25 antigen, to proceed into the clinic with a phase I safety and immunogenicity study.

Elusys Therapeutics Inc., of Pine Brook, N.J., said it completed enrollment in three phase III safety studies of ETI-204, an anti-toxin in development for the treatment of inhalational anthrax. The first, a double blind, randomized, placebo-controlled study, is assessing the safety and tolerability of a single intravenous (IV) dose (16mg/kg) of ETI-204 in 280 adult volunteers. Subjects are being randomized in a 3:1 ratio, with 210 subjects receiving ETI-204 and 70 subjects receiving placebo. This study also will evaluate the bioavailability and pharmacokinetics, as well as the immunogenicity of the anti-toxin. A second study is evaluating the safety and tolerability of repeat IV administration of ETI-204 (16mg/kg) in 70 adult subjects, as well as the pharmacokinetics and immunogenicity of the anti-toxin. Study subjects are being randomized in a one-to-one ratio, to receive ETI-204 on days 1 and 14 and placebo on day 120 of the study, or ETI-204 on days 1 and 120 and placebo on day 14. The company also has completed enrollment for a phase III study to assess the safety and tolerability of ETI-204 when given with oral ciprofloxacin, an antibiotic used to treat anthrax infection after inhalational exposure. Forty adult volunteers were randomized into two groups. The first group is receiving IV ETI-204 (16mg/kg) followed by a single dose of IV ciprofloxacin (400mg), followed by oral ciprofloxacin (750mg) every 12 hours on days two through eight and one final dose of the antibiotic on the morning of day nine. The second group is receiving IV ETI-204 alone. The company also reported it completed enrollment in an additional study to evaluate the tolerability and pharmacokinetics of intramuscular administration of ETI-204 in an additional 20 adult volunteers. ETI-204 is a potential target for future acquisition into the Strategic National Stockpile, the U.S. government’s repository of critical medical supplies for biowarfare preparedness.

Relypsa Inc., of Redwood City, Calif., said patient enrollment for its phase I onset-of-action trial with patiromer for the treatment of hyperkalemia has been completed. This is the final clinical trial that Relypsa expects to include in its new drug application, planned to be filed with the FDA during the third quarter of 2014.

Sarepta Therapeutics Inc., of Cambridge, Mass., reported new pulmonary function data through week 120 from study 202, a phase IIb open-label extension study of eteplirsen in patients with Duchenne muscular dystrophy. Results through more than two years of treatment showed stable pulmonary function in the intent-to-treat study population (N=12). These data are consistent with previously reported 120-week clinical data showing a general stabilization of walking ability in eteplirsen-treated patients evaluable on the 6-minute walk test.

Spinifex Pharmaceuticals, of Melbourne, Australia, reported the results of its phase II clinical trial of its lead candidate, EMA401, in postherpetic neuralgia in The Lancet. EMA401 is an angiotensin II type 2 (AT2) receptor antagonist under development as a potential first-in-class oral treatment for chronic pain without central nervous system side effects. The trial met its primary endpoint by showing that patients randomized to EMA401 achieved a greater reduction in pain from baseline to the last week of 28 days of treatment than patients randomized to placebo. Analyzing all patients randomized (intent to treat population), the mean pain intensity reduction from baseline after 4 weeks treatment was as follows: EMA401: -2.29; Placebo: -1.60; p = 0.007. A significantly greater proportion of patients on active treatment reported a more than 30 percent reduction in mean pain intensity score compared to baseline, meeting a key secondary endpoint.

Theravectys SAS, of Paris, finalized recruitment of patients for its first anti-HIV therapeutic vaccination trial, currently in progress in France and Belgium. The phase I trial aims to study the safety, tolerance and immunogenicity of its vaccine candidate in 36 patients infected with HIV and undergoing highly active antiretroviral therapy. Preliminary results will be available from June 2014 onwards and definitive results over the next 12 months.

Trevena Inc., of King of Prussia, Pa., stared its first phase I trial with TRV734, an oral treatment for moderate to severe acute and chronic pain. TRV734 is being developed to optimize analgesia while minimizing on-target gastrointestinal and respiratory effects through its biased-ligand mechanism at the mu-opioid receptor, the company said.